Use of a sprayable composition comprising ambroxol

Abstract

The present invention relates to ambroxol hydrochloride for the treatment of acute pharyngitis, wherein ambroxol hydrochloride as a sprayable composition comprising up to 30 mg/ml ambroxol hydrochloride is administered locally in a dose of 1 to 20 mg.

The invention claimed is: 
     
       1. A method of treating acute pharyngitis, the method comprising:
 administering a sprayable composition of ambroxol hydrochloride to a subject with an applicator device such that the sprayable composition is delivered uniformly and locally to only an inflamed region of the oropharynx of the subject without the tongue and other parts of the oral and pharyngeal cavity coming into contact with the sprayable composition, the sprayable composition comprising ambroxol hydrochloride in an amount of 17.86 mg/ml to 30 mg/ml, ethanol, a polysorbate in an amount from 0.05 to 0.5% by weight of the sprayable compostion, a pH-regulating substance to regulate the pH of the sprayable composition within a range of 5.2 to 5.8, a sweetener, and water in an amount of at least 85% by weight of the sprayable composition; 
 wherein two or four sprays from the applicator device provides a dosage of 10 mg ambroxol hydrochloride administered locally to the subject. 
 
     
     
       2. The method according to  claim 1 , wherein the sprayable composition has a viscosity in the range from 1.4 to 1.6 mPa*s. 
     
     
       3. A method of treating acute pharyngitis, the method comprising:
 administering a sprayable composition of ambroxol hydrochloride to a subject with an applicator device such that the sprayable composition is delivered uniformly and locally to only an inflamed region of the oropharynx of the subject without the tongue and other parts of the oral and pharyngeal cavity coming into contact with the sprayable composition, the sprayable composition comprising ambroxol hydrochloride in an amount of 17.86 mg/ml, ethanol, a polysorbate in an amount from 0.05 to 0.5% by weight of the sprayable compostion, a pH-regulating substance to regulate the pH of the sprayable composition within a range of 5.2 to 5.8, a sweetener, and water in an amount of at least 85% by weight of the sprayable composition; 
 wherein two or four sprays from the spray applicator provides a dosage of 10 mg ambroxol hydrochloride, administered locally to the subject. 
 
     
     
       4. An applicator device comprising a spray applicator and a container containing a sprayable composition, wherein the sprayable composition consists of:
 ambroxol hydrochloride in an amount of 17.86 mg/ml to 30 mg/ml; 
 ethanol; 
 a polysorbate in an amount from 0.05 to 0.5% by weight of the sprayable compostion; 
 a pH-regulating substance to regulate the pH of the sprayable composition within a range of 5.2 to 5.8; 
 a sweetener; and 
 water in an amount of at least 85% by weight of the sprayable composition; 
 wherein two or four sprays from the spray applicator provides a dosage of 10 mg ambroxol hydrochloride administered locally to the subject, and the sprayable composition is delivered by the applicator device uniformly and locally to only an inflamed region of the oropharynx of the subject without the tongue and other parts of the oral and pharyngeal cavity coming into contact with the sprayable composition. 
 
     
     
       5. The application device of  claim 4 , wherein the amount of ambroxol hydrochloride in the sprayable composition is 17.86 mg/ml.